Aspectos jurídicos de la nanotecnología frente a COVID 19

AutorLinch Chi Dang / Prof. Dr. Jürgen W. Simon
CargoHanoi Law University (Hanoi, Vietnam)
Páginas15-43
Rev Der Gen H Núm. 57/2022: 15-43
Opinión / Opinion
Legal aspects of nanotechnology vs.
COVID 19
Aspectos jurídicos de la nanotecnología frente a
COVID 19
Linch Chi Dang / Prof. Dr. Jürgen W. Simon
Hanoi Law University (Hanoi, Vietnam)
DOI: 10.14679/2029
Sumario / Summary: 1. Introduction. 2. Overall legal regulations. 3. The question
of safety of nanomaterials. 4. Legal regulation in the field of nanotechnology. 4.1
Precautionary principle as a basis for the regulation of nanotechnology. 4.2 Treatment
in the European Union. 4.3 Regulations. 5. International developments. 5.1 The USA.
5.2 Australia and Canada. 5.3 China, Japan and South Korea. 6. Results.
Resumen / Abstract: Despite the lack of specific regulatory guidelines, many
nanomedicines are on the market and their number is growing steadily. These are
mainly used in cancer therapy because they require persistent toxic compounds and
the tumor landscape is very difficult, which hinders effective drug treatment. The lack
of formal regulation of nanomedicines and the manufacture of nanomaterials for
health-related applications is a worldwide problem. Inconsistency among different
government agencies results in some nanomedicines being classified as medical
devices and others as drugs. Therefore, a global consortium for nanomaterials
regulation should be formed to advance these agendas and issue formal guidance to
the research communities. Currently, in the context of nanomaterials in the European
Union, we are dealing with both binding legal acts and non-binding legal acts, such
as recommendations on the fair conduct of scientific research or on the application
of a uniform definition of nanomaterials.
A pesar de la falta de directrices regulatorias específicas, encontramos en el mercado
un número creciente de nanomedicinas. Se utilizan, sobre todo, en la terapia del
cáncer, ya que requieren compuestos tóxicos persistentes y el paisaje tumoral es muy
difícil, lo que dificulta un tratamiento farmacológico eficaz. La falta de regulación
oficial de los nanomedicamentos y la fabricación de nanomateriales para aplicaciones
relacionadas con la salud es un problema mundial. La incoherencia entre las distintas
agencias gubernamentales hace que algunas nanomedicinas se clasifiquen como
LINCH CHI DANG / JÜRGEN W. SIMON
16 Rev Der Gen H Núm. 57/2022
dispositivos médicos y otras como fármacos. Por lo tanto, debería formarse un
consorcio mundial para la regulación de los nanomateriales con el fin de avanzar en
esta agenda y emitir orientaciones formales para las comunidades investigadoras. En
la actualidad, en el contexto de los nanomateriales en la Unión Europea, encontramos
tanto herramientas jurídicas vinculantes, como no vinculantes; tal es el caso de las
recomendaciones sobre la adecuada realización de investigación científica o sobre
la aplicación de una definición uniforme de los nanomateriales.
Palabras clave / Keywords:
Legal regulation, safety of nanomaterials, European Union: REACH, precautionary
principle, international developments.
Regulación jurídica, seguridad de los nanomateriales, Unión Europea: REACH,
principio de precaución, desarrollo internacional.
1. Introduction
The COVID-19 pandemic has become one of the greatest global health
threats in modern history. Advances in nanotechnology development have
provided relief in the form of rapid diagnostic tests and rapidly developed
vaccines against SARS-CoV-2.1 But legal considerations must be factored into
the development of nanotechnology solutions to global health problems.2
In the European Union (EU), this has been recognized as a key technology
that can provide new and innovative medical solutions to unmet medical
needs.3 There are an increasing number of applications and products that
contain nanomaterials or at least nanotechnology-based claims. The use
of nanotechnology in the development of new drugs is now a part for
pharmaceutical research.4
1 SALAMANCA-BUENTELLO, F., & DAAR, A. S., 2021, Nanotechnology, equity and global health,
Natur Nanotechnology, Volume 16, pp. 358-361 (358).
2 SALAMANCA-BUENTELLO, F., & DAAR, A. S., 2021, Nanotechnology, equity and global health,
Natur Nanotechnology, Volume 16, pp. 358-361 (358); KARIM, E., BAKAR BIN MUNIR, A., and
HAJAR MOHD YASIN, S., 2016, UPDATE: Nanotechnology and International Law Research
Guide, in: Globalex. They give a very good overview of the development of nanotechnology
at international level.
3 SOARES, S., SOUSA, J., PAIS, A., and VITORINO,c., Nanomedicine: Principles, Properties,
and Regulatory Issues, in: Front. Chem., 20 August 2018, https://doi.org/10.3389/
fchem.2018.00360. doi: 10.1093/annhyg/mel071. Epub 2006 Oct 14. Completely different
opinion: Maynard, A. D., Nanotechnology: the next big thing, or much ado about nothing?,
Ann Occup Hyg. 2007 Jan, 51(1), pp. 1-12, doi: 10.1093/annhyg/mel071. Epub 2006 Oct
14.
4 BLEEKER, E.A., DE JONG, W.H., GEERTSMA, R.E., GROENEWOLD, M., HEUGENS, E,H., KOERS-
JACQUEMIJNS, M., et al., 2013, Considerations on the EU defi nition of a nanomaterial:
science to support policy making, in: Reg. Toxicol. Pharmacol. 65, 119-12, doi: 10.1016/j.
yrtph.2012.11.007; Ossa, D. ,2014, Quality Aspects of Nano-Based Medicines SME,
Workshop: Focus on Quality for Medicines Containing Chemical Entities, London, Available
online at: http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2014/04/

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